Kidney Stones, Renal Calculi, Urinary Calculi, Urinary Stones, Urinary Tract Stones
Conditions
Keywords
Urinary Calculi, Urinary Stones, Urinary Tract Stones, Renal Calculi, Kidney Stones, Calculi, Urolithotomy, Ureteroscopy
Brief summary
The objectives of the study are to assess the systemic exposure, safety and efficacy of three concentrations of OMS201 in subjects undergoing retrograde ureteroscopic removal of upper urinary tract stones.
Detailed description
The main objective is to estimate the systemic exposure of OMS201 in retrograde ureteroscopic treatment of upper urinary tract stones. Safety will be assessed by vital signs, laboratory values and adverse events. Exploratory efficacy measures will assess the effect of OMS201 on postoperative pain, duration of surgery and ease of placement of a ureteral access sheath.
Interventions
DRUGVehicle
Stages 1-2: Vehicle irrigation solution during surgery
DRUGOMS201
Stage 1: OMS201 irrigation solution at 3X the base concentration during surgery Stage 2: OMS201 irrigation solution up to 10X the base concentration during surgery
Sponsors
Omeros Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 18 - 65 years of age. * Subject is undergoing retrograde ureteroscopic removal of renal-collecting system or ureteral stones for which general anesthesia will be used.
Exclusion criteria
* No allergies to any of the individual ingredients in OMS201. * Subject taking a prohibited medication. * Pregnant woman, nursing mother, or woman of child-bearing age unwilling to take contraception for the duration of the study. * Subject who has had a renal transplant, has a single kidney, has compromised renal function, or has evidence of papillary necrosis. * Subject who has evidence of a clinically significant urinary tract infection. * Subject who has a prior history of open or laparoscopic urinary tract surgery, or a history of a ureteral stricture. * Subject who has congenital anomalies that would engender an increased procedural safety risk. * Subject with a history of clinically significant chronic or episodic hypotension. * Subject's physical examination is significantly abnormal for purposes of the study as determined by the Investigator. * Subject's screening laboratory evaluations are not within normal limits AND abnormal results are determined by the Investigator to be clinically significant. * Subject is at risk from anesthesia. * Subject is on chronic diuretic use. * Subject has a present condition or history of any clinically significant medical disorder and is determined by the Investigator to be an unsuitable candidate for receipt of an investigational drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak systemic exposure. | Day of surgery |
Secondary
| Measure | Time frame |
|---|---|
| Safety | Day 7 |
| Degree of pain | 7 days |
| Duration of the operation | Day of surgery |
| Ease of placement of the ureteral access sheath | Day of surgery |
Countries
United States
Outcome results
None listed